AORTIC AND MITRAL VALVE DISEASE HEMODYNAMICS AND CLINICAL ASPECTS

Transcription

1 2011 Cath Lab Symposium Aug 27, 2011 AORTIC AND MITRAL VALVE DISEASE HEMODYNAMICS AND CLINICAL ASPECTS Basics Mitral stenosis and PMBV Aortic stenosis and PABV TAVI HOCM and ASA (case presentation) Luis F. Tami, MD Cath Lab Director Memorial Regional Hospital

2 Pressure Units in Cath Lab PRESSURE measurements: force/area - International Units: Newton/m2 (pascal or pa) - In USA: pounds per square inch = psi - At sea level: 1 ATM (760 mmhg) - Equivalence: 1 ATM = 14.7 psi THEN: 1 psi is 51.7 mmhg Then 120/80 mmhg is 2.32/1.55 psi

3 - 900 psi psi LV GRAM Relation of different pressure measurements used in the Cath Lab psi ATM in pressure ( psi) - 0 psi 120/80 mmhg = 2.32/1.55 psi

4 ZERO LEVEL Mid-Axillary line is reference level Placing the transducer 4 cm below the zero level will increase measured pressure by about 3 mmhg

5 Pulmonary Artery Wedge Pressure Wedge pressure represent the pressure at the pulmonary capillary level / pulmonary veins (usually representing LA pressure) A true Wedge Pressure is measured ONLY when blood flow stops A Wedge pressure is confirmed if: - Characteristic waveform is present and mean is lower than mean PA - 02 Sat is greater than 95% - Angiographic confirmation of a wedge position with no flow

6 No real wedge. Still some flow around the balloon.

7 Real Wedge: either with balloon or catheter itself

8 Arterial Pressure Waveform from central to peripheral artery in a Healthy 30- year old man

9 CENTRAL AORTA REFLECTED WAVEFORM PERIPHERAL WAVEFORM

10 AO VALVE OPEN MV VALVE OPEN

11 MITRAL STENOSIS: RHEUMATIC

12 - CARDIOPULMONARY BYPASS - INCISION AT RA

13 INCISION LA AND IAS TO EXPOSE MV

14 MV EXPOSED FROM ABOVE

15 MITRAL COMMISSUROTOMY

16 PMBV: INOUE BALLOON Two latex layers, between which is polyester micromesh PMVB: Commissural splitting is main mechanism of action

17 BEFORE AFTER BALOONING

18 57 yr old female with h/o rheumatic fever at age 12 in Jamaica c/o DOE class III NYHA despite BB. Had open commissurotomy in her 30s. TTE c/w MS and AVA 1.4, mild MR and PAP mmhg. TEE done. Wilkins score < 8.

19 MITRAL STENOSIS

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21 RA AND LA SILHOUETTES RA LA

22 ICE: Transeptal Puncture

23 SEPTAL DILATATTION (14F DILATOR)

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25 INOUE BALLOON INFLATION

26 INOUE BALLOON

27 AFTER FIRST INFLATION 24 MM

28 FINAL AFTER SECOND INFLATION 25 MM

29 FINAL

30 MILD MR AFTER PROCEDURE

31 FINAL MV OPENING

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33 Mitral Balloon Valvuloplasty PMV Technique SINGLE BALLOON (2.5%) Mixed (0.5%) INOUE (25%) DOUBLE BALLOON (72%) Palacios IF, et al. Circulation 2002; 105:

34 Mitral Balloon Valvuloplasty COMPLICATIONS Procedure Mortality 0.6% In-Hospital Mortality 1.9% Severe (4 +) MR 2.7% Emergency MVR 1.4% Tamponade 0.8% Stroke 1.2% Palacios IF, et al. Circulation 2002; 105:

35 PMBV Vs Open Surgical Commissurotomy (n=60 patients) Reyes V et al. N Engl J Med 1994;331:

36 2006 AHA/ACC GUIDELINES In centers with skilled, experienced operators, percutaneous balloon valvotomy should be considered the INITIAL PROCEDURE OF CHOICE for symptomatic patients with moderate to severe mitral stenosis who have a favorable valve morphology in the absence of significant MR or LA thrombus.

37 Aortic Stenosis Pathology Normal Degenerative Calcified Bicuspid Rheumatic

38 Aortic Stenosis Currently Normal Degenerative Calcified Bicuspid X Rheumatic

39 NO GRADIENT PRESSURE GRADIENT ACROSS AORTIC VALVE GRADIENT

40 CATHSAP6: Coronary Angiography and Intervention

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44 Langston Dual Lumen Catheter Available since 2005

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46 Aortic Stenosis Severity Severity Area Mean gradient (cm2) (mmhg) MILD >1.5 < 25 HAKKE FORMULA: MODERATE C.O AVA = Sq root Peak-to-peak gradient SEVERE < 1.0 > 40

47 AORTIC STENOSIS IS LIFE-THREATENING AND MAY PROGRESS RAPIDLY! TREATMENT OPTIONS AND TIMING MATTERS Survival Percent Latent Period (Increasing Obstruction, Myocardial Overload) Onset severe symptoms Angina Syncope Failure Avg. survival Years Age Years Survival after onset of symptoms is 50% at two years and 20% at five years. 1 Surgical intervention [for severe AS] should be performed promptly once even minor symptoms occur. 2 Sources: 1 S.J. Lester et al., The Natural History and Rate of Progression of Aortic Stenosis, Chest C.M. Otto, Valve Disease: Timing of Aortic Valve Surgery, Heart 2000 Chart: Ross J Jr, Braunwald E. Aortic stenosis. Circulation. 1968;38 (Suppl 1):61-7.

48 82 yr old Aortic Stenosis. Baseline aortic valve gradient: 70 mmhg. LV AO

49 4 V2

50 CATH LAB ECHO LAB Peak-to- Peak Gradient 71 mmhg Max Gradient 84 mm Hg Mean Gradient: 65 mmhg Mean Gradient: 64 mmhg

51 AR MR

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53 Porcelain Aorta

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61 Initiating and terminating pacing require clear communication between members of the implant team A clear script can be used : Physician: Prepare to pace at 220 beats per minute. Nurse ensures pulse generator rate is set at 220 beats per minute Nurse: Ready to pace at 220 beats per minute. Physician: Start pacing. Nurse initiates pacing. Nurse: Pacing. Physician: Stop pacing. Nurse terminates pacing. Nurse: Pacing stopped.

62 Post PABV: Peak gradient mmhg

63 BEFORE AFTER

64 MECHANISM OF PABV DILATATION 1. Annular and leaflet stretch 2. Microfracture of valvular calcium 3. Commissural separation: not important

65 HEMODYNAMIC RESULTS AVA: From mean 0.5 cm 2 increased to 0.8 cm 2 (71% had a final AVA < 1cm 2 ) Valve area cm Pre Post Lewin (125) Ferguson (73) Kuntz (205) Safian (170) Block (55) Cribier (334) NHLBI (674) Mansfield (492) Davidson (170)

66 NYHA FUNCTIONAL CLASS NHLBI PABV REGISTRY (N=672) # Patients 80% OF PATIENTS FEEL BETTER I n=56 II n=70 I n=214 78% } III n=203 IV n=155 II n=124 III n=116 IV n=30 } 22% BASELINE 30 DAY Bashore, Davidson, Berman et al Circulation 1991: vol 84 no. 6

67 BALLOON AORTIC VALVULOPLASTY LONG TERM OUTCOMES Event Free Survival yr 2-yr 3-yr 75% 62.5% 54% 50% 25% 10% Months Kuntz R NEJM 1991;325:17

68 BALLOON VALVULOPLASTY: 2008 ACC/AHA GUIDELINES: INDICATIONS Class IIb PABV might be reasonable as a bridge to surgery in hemodynamically unstable adult patients with AS who are at high risk for AVR. BAV might be reasonable for palliation in adult patients with AS in whom AVR cannot be performed because of serious comorbid conditions. Evolving Indications BAV as a bridge to transcatheter AVR Diagnostic intervention on low output/ low gradient AS to predict response to transcatheter AVR, (afterload mismatch vs. intrinsic contractility depression)

69 TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) THE FUTURE IS HERE! TAVR is the MOST EXCITING new procedure in interventional cardiovascular therapeutics!!!

70 Dr. Alain Cribier First-in-Man TAVI Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis First Human Case Description Alain Cribier, MD; Helene Eltchaninoff, MD; Assaf Bash, PhD; Nicolas Borenstein, MD; Christophe Tron, MD; Fabrice Bauer, MD; Genevieve Derumeaux, MD; Frederic Anselme, MD; François Laborde, MD; Martin B. Leon, MD AHA; Nov, 2002 April 16, 2002

71 EDWARDS SAPIEN XT THV Cobalt Frame & New Leaflet Geometry Tissue Attachment Sapien XT

72 Sapien XT + NovaFlex Delivery System 18 Fr profile

73 Transcatheter AVR Femoral and Trans-apical Access Transfemoral Transapical

74 AORTIC STENT VALVE IMPLANTED Coronary ostium Stent struts Stent-valve leaflets

75 CoreValve Self-Expanding HIGHER PART: low radial force area axes the system and increases quality of anchoring Aortic Bioprosthesis MIDDLE PART: functional valve area with three leaflets and constrained to avoid coronaries (convexo-concave) avoids need for rotational positioning LOWER PART: high radial force of the frame pushes aside the native calcified leaflets for secure anchoring and avoids recoil and para-valvular leaks A porcine pericardial tissue valve fixed to the frame with PTFE sutures

76 PARTNER Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened N = 699 High Risk Total = 1,057 patients 2 Parallel Trials: Individually Powered Inoperable N = 358 Yes ASSESSMENT: Transfemoral Access No ASSESSMENT: Transfemoral Access Transfemoral (TF) Transapical (TA) Yes No 1:1 Randomization 1:1 Randomization 1:1 Randomization Not In Study N = 244 N = 248 N = 104 N = 103 N = 179 N = 179 TF TAVR VS AVR TA TAVR VS AVR TF TAVR VS Standard Therapy Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority) Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority)

77 TAVI Inoperable group: Outcomes

78 All-cause mortality (%) All Cause Mortality Standard Rx TAVI at 1 yr = 20.0% NNT = 5.0 pts 50.7% 30.7% Months Numbers at Risk TAVI Standard Rx

79 per cent CLINICAL OUTCOMES AT 30 DAYS AND 1 YEAR Death - All Cause P = P = 0.41 TAVI (n=179) Standard Rx (n=179)

80 PARTNER QOL ANALYSES TAVI not only added years to life, but also, life to years!

81 PARTNER PERSPECTIVES - INOPERABLE The HEART VALVE TEAM approach is preferred Standard therapy is associated with a prohibitive 1-year mortality. TAVI resulted in Low (~5%) 30-day mortality Historic reduction in 1-year mortality Improved symptoms in survivors New complications (e.g. strokes, vascular) Balloon-expandable TAVR is the new standard-of-care for inoperable patients with severe AS!

82 TAVI High Risk Group: OUTCOMES

83 ALL-CAUSE MORTALITY OR STROKE ALL PATIENTS (N=699) HR [95% CI] = 0.95 [0.73, 1.23] P (log rank) = No. at Risk Months TAVR AVR

84 PARTNER PERSPECTIVES - HIGH RISK TAVI and AVR procedural mortality were similar and better than anticipated (30 days: TAVR 3.4%, AVR 6.5%, P=0.07). Mortality at 1-year was also similar TAVI resulted in Earlier improvement in symptoms (same at 1-year) Improved echo AV gradients-areas (small difference) Different peri-procedural hazards TAVI increased strokes, vascular complics and AVR increased bleeding and new onset AF

85 PARTNER - HIGH RISK Balloon-expandable TAVR is a new alternative therapy to surgical AVR in selected high-risk patients with severe AS!

86 NEW TAVI TECHNOLOGIES Direct Flow Sadra AorTx Jena Valve HLT ABPS PercValve EndoTech Ventor Embracer Symetis